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March 8, 2026
Approximately 5 minutes
Planning Pediatric Drug Development Programs During Adult Drug Development in Japan
1. Publication Details
Issued January 12, 2024 (provisional translation as of April 2024). From Director, Pharmaceutical Evaluation Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare. https://www.pmda.go.jp/files/000268525.pdf
2. Background
Drugs for pediatric use have more difficulties in clinical development compared to those for adults despite high medical needs. In the U.S. and EU, pharmaceutical companies are required to submit pediatric drug development plans at an early stage of adult drug development. In Japan, to promote pediatric drug development and resolve drug loss, it is desirable for applicants to prepare and confirm pediatric plans with PMDA before filing adult approval applications. https://www.pmda.go.jp/files/000268525.pdf
3. Policy Intent
The notification aims to encourage timely pediatric drug development by having applicants prepare development plans during adult drug development and confirm them with PMDA, proceeding without delay based on the plan. This applies even if pediatric indications differ from adults, such as in cancer treatments. https://www.pmda.go.jp/files/000268525.pdf
4. Target Products
Applies to drugs for pediatric use (pediatric drugs) developed alongside or following adult drugs, particularly where clinical development is challenging but medical needs are high. Includes cases where pediatric and adult indications may differ. https://www.pmda.go.jp/files/000268525.pdf
5. Eligibility Types
Eligibility for planning includes drugs where pediatric subjects can be evaluated with adults, or separate pediatric indications. Confirmation is desirable before adult approval filing, or by review end if difficult. https://www.pmda.go.jp/files/000268525.pdf
6. Consultation Pathway Before Approval
Applicants should confirm the pediatric drug development plan with PMDA before filing the adult approval application. If difficult, confirm by the end of the review. For differing indications (e.g., different cancer types), confirmation is still encouraged. https://www.pmda.go.jp/files/000268525.pdf
7. Approval Application and Review Expectations
During the approval process for adult drugs, include the pediatric plan if confirmed. Proceed with pediatric development without delay based on the prepared plan. https://www.pmda.go.jp/files/000268525.pdf
8. Procedure After Approval (Post-marketing Obligations)
Post-approval, implement the confirmed pediatric development plan promptly. The notification does not specify mandatory post-approval steps but emphasizes proceeding without delay. https://www.pmda.go.jp/files/000268525.pdf
9. Practical Considerations
This does not prevent confirmation for drugs with different adult/pediatric indications. The focus is on resolving delays in pediatric access compared to global standards. Related documents include partial revisions (PSB/PED Notification No. 0329-1, March 29, 2024) and Q&A (Administrative Notice, March 29, 2024). https://www.pmda.go.jp/files/000268525.pdf
10. Effective Date
The notification is effective from January 12, 2024. https://www.pmda.go.jp/files/000268525.pdf
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